510(k) K841008
K841008 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "BIOPSY PUNCH, VARIOUS". The FDA issued a decision of Substantially Equivalent on June 8, 1984. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1984
- Date Received
- March 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Biopsy, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type